International Journal of Pharmacy

Size: px
Start display at page:

Download "International Journal of Pharmacy"

Transcription

1 International Journal of Pharmacy Journal Homepage: Research Article CDEN: IJPNL6 PLASMA PRTEIN BINDING STUDY F METAXALNE WITH HUMAN PLASMA BY RP-HPLC Kasture Veena S, Mhaske Sharayu D*, Pathan Mallika A, Waman Nitesh, Ajage Rohit K Department of Quality Assurance Techniques, Sanjivani College of Pharmaceutical Education and Research, Kopargaon, MS, India *Corresponding author sharayumhaske@yahoo.com ABSTRACT The HPLC method was developed and validated to quantify Metaxalone binding with human plasma. Metaxalone was extracted from spiked plasma by simple protein precipitation with methanol. The seperation was performed on RP-C18 column with mobile phase of HPLC grade methanol at a flow rate of 1 ml/min. The peak of Metaxalone was monitored at 272 nm with UV-VIS detector. The calibration curve was found to be linear at concentration range of 1-8 μg/ml. Regression was found to be The interday and intraday precisions SD and RSD were and 0.515, 1.851% and 1.648%. respectively. The recovery of Metaxalone from formulation was 96.97±2.14% and from plasma was found to be 84%. Plasma protein binding was found to be 16.90±1.67. The developed method was validated as per ICH guidelines.the simple, rapid, sensitive and reproducible HPLC method was developed for estimation of Metaxalone plasma protein binding.. The proposed method can be used for the pharmacokinetic and bioequivalence studies of Metaxalone. Keywords: Metaxalone, HPLC method development, Plasma Protein binding, Human plasma. INTRDUCTIN Metaxalone is 5-[(3,5 dimethylphenoxy)methyl]-2- oxazolidinone with molecular formula C 12 H 15 N 3 and molecular weight of , a skeletal muscle relaxant drug marketed by King pharmaceuticals. Skeletal muscle relaxants have been used for either treatment of spasticity or for treatment of musculoskeletal conditions. Metaxalone is used to relax muscles and relieve pain caused by strains, sprains, and other musculoskeletal conditions. Its exact mechanism of action is not known but it may be due to general central nervous system depression. [1,2] Protein binding of Metaxalone is not known [1]. Literature survey revealed that only few methods were reported for quantification of Metaxalone in plasma by liquid chromatography. [3] These methods reported the recovery of Metaxalone from plasma but no method reported about binding of Metaxalone to human plasma. Since the protein binding study was not much reported for Metaxalone, in present study, the human plasma protein binding of Metaxalone was studied. The developed chromatographic seperation method is useful for pharmacokinetic and bioequivalence studies of Metaxalone containing formulations. [4] MATERIALS AND METHDS Instruments 1. HPLC, SHIMADZU (isocratic) with LC-20 AD pump, SPD-20A detector system and spinchrom software 2. Cyclomixer, 101 Remi 3. Centrifuge, Remi 4. Sonicator, Sidilu ultrasonics-1.5l50h Materials Standard Metaxalone was obtained as a gift sample from Angelini pharmaceuticals Ltd. and HPLC grade methanol was obtained from Research lab fine chem industry, Mumbai. Drug free human plasma was purchased from local blood bank of Kopargaon

2 Tablets of Metaxalone (FLEXURA 400 Sun pharma Sikkim), were procured from local market of Kopargaon. Preparation of standard stock solution: Stock solution of Metaxalone was prepared in methanol at a concentration of 100 μg/ml and was kept at C. Stock solution was diluted with methanol to obtain the concentrations of 1-8 μg/ml. Preparation of Quality Control Standards: Lowest quality control standards (LQC), median quality control standards (MQC) and highest quality control standards (HQC) were prepared by spiking 0.25 ml drug free plasma with Metaxalone to give samples containing 3, 5, 8 μg/ml of Metaxalone respectively and were stored at 4 0 C till analysed. [5] Chromatographic conditions: 6 The chromatographic seperation of Metaxalone was done using RP-C18 (250mmx4.6mm), 5μ column(phenomenex). The mobile phase was HPLC grade methanol. Flow rate was maintained at 1ml/min. Total run time of analysis was 10 min.the peaks were determined using UV-VIS detector set at a wavelength of 272 nm. Retention time was found to be min. Injection volume was 20 μl. All the procedures were performed at ambient temperature. The mobile phase was selected after trial and error basis in which the composition of methanol, water and acetonitrile were tried but sharp peak was not resulted. The asymmetry of peak was minimum with pure methanol. Extraction procedure for plasma protein binding study [7] Appropriate quantity of metaxalone solution was spiked with 0.25 ml of plasma to produce 1-8 μg/ml. The mixture was vortexed for 2 min. and kept overnight. n next day the mixure was centrifuged at 4000 rpm for 30 min. The supernatant solution was seperated from settled plasma. 10ml of methanol was added to settled plasma and was vortexed for 30 min. for complete extraction of Metaxalone from plasma. The PTFE syring filter was firstly preconditioned with methanol. and extracted Metaxalone solution was passed through 0.45 μ PTFE Syringe filter. The resultant filtrate of 20 μl was injected into HPLC system for analysis. HPLC method validation [8] System suitability parameters: The AUC of respective concentrations, theoretical plates (Efficiency), peak symmetry (Tailing factor) was recorded. Linearity: Dilutions of standard solution of metaxalone in the range of 1-8 μg/ml were prepared by taking suitable aliquots of standard solutions in different 10 ml of volumetric flasks and diluting upto the mark with methanol. 20 μl of the resultant was injected, at each time into the column at flow rate of 1ml/min. the standard solution was monitored at 272 nm. A plot of peak area over concentration was constructed. Regresssion of the plot was computed by least square regresssion method of analysis. Precision: Precision of analytical method was studied by multiple injection of homogeneous sample. 5 replicates of 3 ppm were prepared and injected for precision at same flow rate of 1 ml/min. the SD and %RSD were calculated. Robustness: Robustness was studied by changing parameters like change in flow rate. The flow rate was kept 0.8 ml/min. The SD and %RSD were calculated. Ruggedness: Analyst was changed for ruggedness study. The SD and %RSD were calculated LD and LQ: Limit of detection and limit of quantitation of method was calculated by formula given below LD=3.3x SD / Slope LQ=10x SD / Slope Accuracy:Accuracy of the method was studied using the standard addition method. The % recovery was determined at three different levels (50%, 100% and 150%). RESULTS AND DISCUSSIN Develpoment and Validation of HPLC method The Metaxalone peak was appeared at min. (Figure 1). The system suitability parameters for developed HPLC method was stated in table 1. The HPLC method was developed and validated for analysis of Metaxalone plasma binding. Calibration curve showed linear relationship between concentration and area at 272 nm in concentration range of 1-8μg/ml. The regression was found to be The regression equation was y= x (Figure 2). Standard deviation and % RSD for precision was found to be and 1.532% respectively. Standard deviation and % RSD for interday and intraday precision was found to be 0.576, 1.851% and % respectively. The standard deviation and %RSD for ruggedness and robustness were found to be 0.476, 1.533% and 0.569, 1.817% respectivly (Table 2). Limit of detection was found to be 0.152μg/ml and limit of quantitation was found to be μg/ml. Accuracy 200

3 was found to be 96.97% (Table 3). The values were within the limit specified by ICH guidelines. Hence method was found to be precise, rugged and robust. [8] Plasma protein binding study of Metaxalone: Percentage of plasma protein binding was calculated by: %protein binding = Area of bound drug x100 Area of standard drug Plasma protein binding of Metaxalone was found to be 16.90±1.67%. CNCLUSIN Metaxalone is poorly water soluble muscle relaxant drug of which protein binding is not reported in literature. In the proposed study Metaxalone binding with human plasma (in vitro) was studied. The plasma binding was quantified by validated isocratic HPLC method. Plasma protein binding of Metaxalone was found to be 16.90%. The developed method was sensitive, accurate, precise bioanalytical method. The proposed method canbe successfully applied for pharmacokinetic and bioequivalence studies. ACKNWLEDGEMENTS We wish to express our sincere thanks to Dr. Kasture Sanjay B. Principal, Sanjivani College of Pharmaceutical Education and Research, Kopargaon for providing necessary facilities. HN H 3 C CH 3 Metaxalone Figure 1: Chromatogram of Standard 5 ppm Metaxalone Figure 2: Calibration curve of Metaxalone at 272 nm (Concentration vs. Area) 201

4 Figure 3: Chromatogram of Metaxalone bound to plasma (3ppm) Figure 4: Chromatogram of Metaxalone bound to plasma (5ppm) Figure 5: chromatogram of Metaxalone bound to plasma (8 ppm) Table 1:Results of system suitability parameters Sr. no. Concentration (ppm) Retention Time Asymmetry Efficiency Table 2: Results of Precision by HPLC Parameters SD %RSD Precision % Interday Precision % Intraday Precision % Ruggedness % Robustness % 202

5 Table 3: Results of accuracy by HPLC Sr No Concentration (ppm) 1ppm test+2ppm standard 1ppm test+3ppm standard 1ppm test+4ppm standard Mean Area Area of standard %Recovery 94.66% % 98.91% Table 4: Summary of HPLC Method validation Sr no. Parameter bservation 1. Linearity range 1-8 μg/ml 2. Slope Intercept Correlation Coefficient Precision SD %RSD Interday Precision SD %RSD Intraday Precision SD %RSD Ruggedness SD Robustness %RSD SD %RSD Accuracy 96.97% 11. LD 0.152μg/ml 12. LQ 0.461μg/ml Table 5: Results for plasma protein binding of Metaxalone Sr. no. Concentration Mean area of Area of std. % Binding (ppm) bound drug drug % % % REFERENCES 1. DrugBank, pen Data Drug and Drug Target Database approved by FDA, 2. Wikipedia: The Free Encyclopedia, 3. Karthikeyan Kandasamy, Vasantharaju Surenahalli Gowdra, Hariprabhu Nammalvar, Arulkumaran Kottur S Govindarajan. J. Bioanal Biomed, 2012; S6: Pavan Balabathula, Dileep R Janagam, Nivesh K Mittal, Bivash Mandal, Laura A Thoma and George C Wood. J. Bioequiv Availab, 2013; 5(3): Guidance for Industry Bioanalytical Method Validation, U.S. Department of Health and Human Services FDA, CDER, CVM, BP 2001; Khan Imran, Saraf Madhusudan Natvarlal, Sayyed Nazim. Int. J. ChemTech Res, 2011; 3(4): Dhaval S. Thakar, Alice Varghese. Int. J. Pharm. Biosci. Technol, 2013; 1(1): ICH Q2B: Guidance for Industry: Validation of Analytical procedures:methodology, U. S. Department of Health and Human services Food and Drug Administration, CDER, CBER, 1996;

N. Tamilselvi *, Dona Sara Kurian. Department of Pharmaceutical Analysis. KMCH college of pharmacy Coimbatore

N. Tamilselvi *, Dona Sara Kurian. Department of Pharmaceutical Analysis. KMCH college of pharmacy Coimbatore BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF PIRFENIDONE BY RPHPLC METHOD AND ITS APPLICATION TO THE DETERMINATION OF DRUG FOOD INTERACTION STUDY IN WISTER RATS ABSTRACT N. Tamilselvi *, Dona Sara

More information

RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF GLATIRAMER ACETATE FOR INJECTION IN PHARMACEUTICAL DOSAGE FORMS

RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF GLATIRAMER ACETATE FOR INJECTION IN PHARMACEUTICAL DOSAGE FORMS RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF GLATIRAMER ACETATE FOR INJECTION IN PHARMACEUTICAL DOSAGE FORMS ABSTRACT A simple RP-HPLC method for the determination of Glatiramer acetate in pharmaceutical

More information

Validated Stability-indicating assay method for determination of Ilaprazole in bulk drug and tablets by high performance liquid chromatography

Validated Stability-indicating assay method for determination of Ilaprazole in bulk drug and tablets by high performance liquid chromatography Validated Stability-indicating assay method for determination of Ilaprazole in bulk drug and tablets by high performance liquid chromatography Pradeep G. Shelke a*, Anil V. Chandewar a, Anil P. Dewani

More information

Research Paper Development of Stability Indicating Reverse Phase HPLC Method for Aripiprazole from Solid Dosage form

Research Paper Development of Stability Indicating Reverse Phase HPLC Method for Aripiprazole from Solid Dosage form International Journal of Pharmaceutical Sciences and Nanotechnology 572 International Journal of Pharmaceutical Sciences and Nanotechnology Volume 2 Issue 2 July - September 2009 Volume 2 Issue 2 July

More information

Available Online through (or) IJPBS Volume 2 Issue 3 JULY-SEPT Research Article Pharmaceutical Sciences

Available Online through  (or)  IJPBS Volume 2 Issue 3 JULY-SEPT Research Article Pharmaceutical Sciences Page1 Research Article Pharmaceutical Sciences RP-HPLC DETERMINATION OF RELATED SUBSTANCES OF TAPENTADOL IN BULK AND PHARMACEUTICAL DOSAGE FORM EDIGA SASI KIRAN GOUD* 1, V.KRISHNA REDDY 2 * 1,2 Department

More information

Size Exclusion Chromatography of Biosimilar and Innovator Insulin Using the Agilent AdvanceBio SEC column

Size Exclusion Chromatography of Biosimilar and Innovator Insulin Using the Agilent AdvanceBio SEC column Size Exclusion Chromatography of Biosimilar and Innovator Insulin Using the Agilent AdvanceBio SEC column Application Note Bio-Pharmaceutical Authors M. Sundaram Palaniswamy and Andrew Coffey Agilent Technologies,

More information

Development & Validation of RP-HPLC Method for Estimation of Dabigatran Etexilate Mesylate from Capsule Dosage Form

Development & Validation of RP-HPLC Method for Estimation of Dabigatran Etexilate Mesylate from Capsule Dosage Form Development & Validation of RP-HPLC Method for Estimation of Dabigatran Etexilate Mesylate from Capsule Dosage Form Bhavna Patel 1,Shoumik Roy 1,Hardik Ghelani 2, Shraddha Parmar 1 * 1 Post Graduation

More information

International Journal of Pharma Research & Review, Feb 2014; 3(2):11-16 ISSN:

International Journal of Pharma Research & Review, Feb 2014; 3(2):11-16 ISSN: Research Article Determination of Methyl Methanesulfonate, Ethyl Methanesulfonate and Isopropyl Methanesulfonate Impurities in Lopinavir API by GC/MS/MS using Electron Ionization Veenaeesh P, *Manikumar

More information

Developing Robust and Efficient IEX Methods for Charge Variant Analysis of Biotherapeutics Using ACQUITY UPLC H-Class System and Auto Blend Plus

Developing Robust and Efficient IEX Methods for Charge Variant Analysis of Biotherapeutics Using ACQUITY UPLC H-Class System and Auto Blend Plus Developing Robust and Efficient IEX Methods for Charge Variant Analysis of Biotherapeutics Using ACQUITY UPLC H-Class System and Auto Blend Plus Robert Birdsall, Thomas Wheat, and Weibin Chen Waters Corporation,

More information

Development of Quality Control Method for Dissolution Analysis of Tapentadol and paracetamolin tablet

Development of Quality Control Method for Dissolution Analysis of Tapentadol and paracetamolin tablet Original Research Article Development of Quality Control Method for Dissolution Analysis of Tapentadol and paracetamolin tablet Krishna R Gupta 1,*, Kiran N. Kale 2 1 Professor, 2 Phd. Scholar, SKB College

More information

Research Article Development and Validation of Acyclovir HPLC External Standard Method in Human Plasma: Application to Pharmacokinetic Studies

Research Article Development and Validation of Acyclovir HPLC External Standard Method in Human Plasma: Application to Pharmacokinetic Studies Advances in Pharmaceutics, Article ID 284652, 5 pages http://dx.doi.org/10.1155/2014/284652 Research Article Development and Validation of Acyclovir HPLC External Standard Method in Human Plasma: Application

More information

A green HPLC technique with a 100% water mobile phase for detecting imidacloprid and its metabolite 6-chloronicotinic acid

A green HPLC technique with a 100% water mobile phase for detecting imidacloprid and its metabolite 6-chloronicotinic acid Current Chemistry Letters 5 (2016) 27 32 Contents lists available atgrowingscience Current Chemistry Letters homepage: www.growingscience.com/ccl A green HPLC technique with a 100% water mobile phase for

More information

International Journal of Medicine and Nanotechnology

International Journal of Medicine and Nanotechnology International Journal of Medicine and Nanotechnology Access online at www.medtechnano.com Original Article Method Development and Validation for the Simultaneous Estimation of Doxycycline and Ornidazole

More information

Validation of a concentration assay using Biacore C

Validation of a concentration assay using Biacore C GE Healthcare Application Note 48 Biacore systems Validation of a concentration assay using Biacore C Guideline for development of a GxP - compliant concentration assay Support for informed decision-making

More information

Quantitative determination of residual 2-(2-chloroethoxy) ethanol (CEE) in quetiapine fumarate by gas chromatogaraphy

Quantitative determination of residual 2-(2-chloroethoxy) ethanol (CEE) in quetiapine fumarate by gas chromatogaraphy Advances in Bioscience and Biotechnology, 2010, 1, 367-371 doi:10.4236/abb.2010.15049 Published Online December 2010 (http://www.scirp.org/journal/abb/). Quantitative determination of residual 2-(2-chloroethoxy)

More information

A Sub-picogram Quantification Method for Desmopressin in Plasma using the SCIEX Triple Quad 6500 System

A Sub-picogram Quantification Method for Desmopressin in Plasma using the SCIEX Triple Quad 6500 System A Sub-picogram Quantification Method for Desmopressin in Plasma using the SCIEX Triple Quad 6500 System A high-throughput method for detecting ultra-low levels (0.5 pg/ml) of a therapeutic peptide in human

More information

INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON ARTEMETHER AND LUMEFANTRINE CAPSULES REVISED DRAFT FOR DISCUSSION

INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON ARTEMETHER AND LUMEFANTRINE CAPSULES REVISED DRAFT FOR DISCUSSION October 2007 RESTRICTED ` INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON ARTEMETHER AND LUMEFANTRINE CAPSULES REVISED DRAFT FOR DISCUSSION World Health Organization 2007 All rights reserved. This draft is intended

More information

Method development and validation for the quantitative estimation of cefixime and ofloxacin in Pharmaceutical preparation by RP- HPLC

Method development and validation for the quantitative estimation of cefixime and ofloxacin in Pharmaceutical preparation by RP- HPLC Available online at www.derpharmachemica.com Scholars Research Library Der Pharma Chemica, 2014, 6(2):31-37 (http://derpharmachemica.com/archive.html) ISSN 0975-413X CODEN (USA): PCHHAX Method development

More information

HPLC METHODOLOGY MANUAL

HPLC METHODOLOGY MANUAL HPLC METHODOLOGY MANUAL DISTRIBUTED PHARMACEUTICAL ANALYSIS LABORATORY (DPAL) Revision Date 2016-08-04 Professor Marya Lieberman Department of Chemistry and Biochemistry University of Notre Dame Notre

More information

Forced degradation studies and validated stability indicating HPTLC method for determination of miconazole nitrate in soft lozenges

Forced degradation studies and validated stability indicating HPTLC method for determination of miconazole nitrate in soft lozenges Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2012, 4 (6):1793-1804 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4

More information

Kalyani G. et al.; International Journal of Pharmamedix India, 2013, 1(2),

Kalyani G. et al.; International Journal of Pharmamedix India, 2013, 1(2), Kalyani G. et al.; International Journal of Pharmamedix India, 2013, 1(2), 222-232. Stability Indicating Method Development and Validation of Candesartan in Bulk and Pharmaceutical Dosage Form by Derivative

More information

Bioanalytical method validation: An updated review

Bioanalytical method validation: An updated review Review Article www.phmethods.org Bioanalytical method validation: An updated review Abstract The development of sound bioanalytical method(s) is of paramount importance during the process of drug discovery

More information

Research Article. Optimization and validation of rapid and simple method for determination of Isoniazid and Pyrazinamide in plasma by HPLC-UV

Research Article. Optimization and validation of rapid and simple method for determination of Isoniazid and Pyrazinamide in plasma by HPLC-UV Available online www.jocpr.com Journal of Chemical and Pharmaceutical Research, 2016, 8(3):165-169 Research Article ISSN : 0975-7384 CODEN(USA) : JCPRC5 Optimization and validation of rapid and simple

More information

QbD approach for analytical method development of anti-pschotic drug

QbD approach for analytical method development of anti-pschotic drug Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2015, 7 (12):62-70 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4

More information

Fusion Analytical Method Validation

Fusion Analytical Method Validation Fusion QbD Software System Fusion Analytical Method Validation The Only Software That Has It All! 100% aligned with FDA/ICH Quality by Design (QbD) guidances! Can be used for LC and Non-LC methods (e.g.

More information

Quality-by-Design-Based Method Development Using an Agilent 1290 Infinity II LC

Quality-by-Design-Based Method Development Using an Agilent 1290 Infinity II LC Quality-by-Design-Based Method Development Using an Agilent 129 Infinity II LC An Efficient Method Development Workflow Combined with ISET-mediated Method Transfer Under Waters Empower 3 CDS Control Application

More information

Determination of Adenovirus pviii (31K) Concentration for Estimation of the Empty Capsid Concentration of the Adenovirus Reference Material (ARM)

Determination of Adenovirus pviii (31K) Concentration for Estimation of the Empty Capsid Concentration of the Adenovirus Reference Material (ARM) Determination of Adenovirus pviii (31K) Concentration for Estimation of the Empty Capsid Concentration of the Adenovirus Reference Material (ARM) Sundari Ravindran, Mei Lin, Gary Vellekamp, (SPRI) Summary:

More information

Optimizing the Purification of a Standard Chiral Compound Utilizing a Benchtop, Multi-Purpose, Semi-Preparative to Preparative HPLC System

Optimizing the Purification of a Standard Chiral Compound Utilizing a Benchtop, Multi-Purpose, Semi-Preparative to Preparative HPLC System Optimizing the Purification of a Chiral Compound Utilizing a Benchtop, Multi-Purpose, Semi-Preparative to Preparative HPLC System Application Note PHA0111 Keywords Chiral, Enantiomer, HPLC, Normal Phase

More information

VICH Topic GL2 (Validation: Methodology) GUIDELINE ON VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY

VICH Topic GL2 (Validation: Methodology) GUIDELINE ON VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit CVMP/VICH/591/98-FINAL London, 10 December 1998 VICH Topic GL2 (Validation: Methodology) Step 7 Consensus

More information

A Modular Preparative HPLC System for the Isolation of Puerarin from Kudzu Root Extracts

A Modular Preparative HPLC System for the Isolation of Puerarin from Kudzu Root Extracts A Modular Preparative HPLC System for the Isolation of Puerarin from Kudzu Root Extracts Andrew Aubin and Ronan Cleary Waters Corporation, Milford, MA, USA APPLICATIN BENEFITS A modular preparative HPLC

More information

Peptide Mapping: A Quality by Design (QbD) Approach

Peptide Mapping: A Quality by Design (QbD) Approach Peptide Mapping: A Quality by Design (QbD) Approach Application Note Bio-Pharmaceutical Authors Sreelakshmy Menon and Suresh babu C.V. Agilent Technologies, Inc. Richard Verseput S-Matrix Corporation Abstract

More information

Improving Resolution and Column Loading Systematically in Preparative Liquid Chromatography for Isolating a Minor Component from Peppermint Extract

Improving Resolution and Column Loading Systematically in Preparative Liquid Chromatography for Isolating a Minor Component from Peppermint Extract Improving Resolution and Column Loading Systematically in Preparative Liquid Chromatography for Isolating a Minor Component from Peppermint Extract Jo-Ann M. Jablonski and Rui Chen Waters Corporation,

More information

Chem 321 Lecture 23 - Liquid Chromatography 11/19/13

Chem 321 Lecture 23 - Liquid Chromatography 11/19/13 Chem 321 Lecture 23 - Liquid Chromatography 11/19/13 Student Learning Objectives High Performance Liquid Chromatography With the advent of relatively inexpensive and reliable pumps, the development of

More information

DETERMINATION OF MYCOTOXINE DEOXYNIVALENOL IN WHEAT FLOUR AND WHEAT BRAN

DETERMINATION OF MYCOTOXINE DEOXYNIVALENOL IN WHEAT FLOUR AND WHEAT BRAN Revue de Cytologie et Biologie végétales-le Botaniste 2005-28 (s.i.): 64-70 DETERMINATION OF MYCOTOXINE DEOXYNIVALENOL IN WHEAT FLOUR AND WHEAT BRAN by F. ISRAEL-ROMING (1) M. AVRAM (2) V. GAGIU (2) G.

More information

Determination of organochlorine pesticide residues in eggs by gel-permeation chromatography (GPC) cleanup and GC-ECD

Determination of organochlorine pesticide residues in eggs by gel-permeation chromatography (GPC) cleanup and GC-ECD Determination of organochlorine pesticide residues in eggs by gel-permeation chromatography (GPC) cleanup and GC-ECD 1. Experimental Section LabTech, Inc. 1.1 Instruments and reagents AutoClean automatic

More information

Novel Rp-Hplc-Pda Method for the Simultaneous Estimation of Metoprolol Succinate and Chlorthalidone in Bulk and Pharmaceutical Dosage Forms

Novel Rp-Hplc-Pda Method for the Simultaneous Estimation of Metoprolol Succinate and Chlorthalidone in Bulk and Pharmaceutical Dosage Forms Research Article Novel Rp-Hplc-Pda Method for the Simultaneous Estimation of Metoprolol Succinate and Chlorthalidone in Bulk and Pharmaceutical Dosage Forms A. Naga Jyothi 1, Syed. Sadath Ali 2, Buchi.

More information

Preparative HPLC is still the

Preparative HPLC is still the B I O P R O C E S S TECHNICAL Optimizing Sample Load Capacity and Separation Through a Series of Short Prep Columns Mark Crawford, Joan Stevens, and Luke Roenneburg Preparative HPLC is still the dominate

More information

Certified Reference Material - Certificate of Analysis

Certified Reference Material - Certificate of Analysis Certified Reference Material - Certificate of Analysis S(-)-Nicotine, Primary Standard N-008 Page 1 of 7 Catalog Number: N-008 H Lot: Expiration: October 2019 N Description: S(-)-Nicotine in Methanol.

More information

Developing and Validating Dissolution Procedures for Improved Product Quality

Developing and Validating Dissolution Procedures for Improved Product Quality W H I T E P A P E R Developing and Validating Dissolution Procedures for Improved Product Quality By Michael Swartz, Ph. D., Director of Research and Development, and Mark Emanuele, Chemist Abstract In

More information

PAHs in Surface Water by PDA and Fluorescence Detection

PAHs in Surface Water by PDA and Fluorescence Detection A P P L I C AT I O N N O T E Liquid Chromatography Authors: Catharine Layton Wilhad M. Reuter PerkinElmer, Inc. Shelton, CT PAHs in Surface Water by PDA and Fluorescence Detection Introduction Heightened

More information

Physical Stability of a Silica- Based Size Exclusion Column for Antibody Analysis

Physical Stability of a Silica- Based Size Exclusion Column for Antibody Analysis Physical Stability of a Silica- Based Size Exclusion Column for Antibody Analysis Atis Chakrabarti* and Roy Eksteen + Tosoh Bioscience LLC, King of Prussia, PA 19406 *Corresponding Author. + Current address:

More information

Determination of Iron Content in Different Hemoglobin Samples from Some Patients by UV-Visible Spectrophotometer

Determination of Iron Content in Different Hemoglobin Samples from Some Patients by UV-Visible Spectrophotometer Advances in Analytical Chemistry 2016, 6(2): 35-40 DOI: 10.5923/j.aac.20160602.01 Determination of Iron Content in Different Hemoglobin Samples from Some Patients by UV-Visible Spectrophotometer Isam Eldin

More information

Genotoxicity is the property of a compound

Genotoxicity is the property of a compound Impurities Analysis in Pharmaceuticals: Genotoxicity is the property of a compound known to have irreversible effects on the structure and functionality of the DNA in cells and cause DNA loss, DNA replication

More information

Agilent AdvanceBio SEC Columns for Aggregate Analysis: Instrument Compatibility

Agilent AdvanceBio SEC Columns for Aggregate Analysis: Instrument Compatibility Agilent AdvanceBio SEC Columns for Aggregate Analysis: Instrument Compatibility Technical Overview Introduction Agilent AdvanceBio SEC columns are a new family of size exclusion chromatography (SEC) columns

More information

Disulfide Linkage Analysis of IgG1 using an Agilent 1260 Infinity Bio inert LC System with an Agilent ZORBAX RRHD Diphenyl sub 2 µm Column

Disulfide Linkage Analysis of IgG1 using an Agilent 1260 Infinity Bio inert LC System with an Agilent ZORBAX RRHD Diphenyl sub 2 µm Column Disulfide Linkage Analysis of IgG1 using an Agilent 126 Infinity Bio inert LC System with an Agilent ZORBAX RRHD Diphenyl sub 2 µm Column Application Note Biotherapeutics & Biosimilars Author M. Sundaram

More information

Laboratory Reagents. for life science research.

Laboratory Reagents. for life science research. Laboratory Reagents Research, quality control, or routine analysis whatever the field of activity, where there is a need for laboratory reagents, Thermo Fisher Scientific has a suitable product. We offer

More information

Validation Report 19

Validation Report 19 EURL for Cereals and Feeding stuff National Food Institute Technical University of Denmark Validation Report 19 Determination of pesticide residues in oat, rye and wheat by GC-MS/MS and LC-MS/MS (QuEChERS

More information

APPLICATION NOTE. Application Note. Summary/Abstract:

APPLICATION NOTE. Application Note. Summary/Abstract: APPLICATION NOTE Characterization of Gold Nanoparticle Detection Using Slope Spectroscopy (SoloVPE Variable Pathlength UV) Application Note The SoloVPE and Slope Spectroscopy offer a new method of Slope

More information

BIOANALYTICAL METHOD DEVELOPMENT AND ITS VALIDATION

BIOANALYTICAL METHOD DEVELOPMENT AND ITS VALIDATION 321 P a g e International Standard Serial Number (ISSN): 2319-8141 International Journal of Universal Pharmacy and Bio Sciences 3(4): July-August 2014 INTERNATIONAL JOURNAL OF UNIVERSAL PHARMACY AND BIO

More information

mab Titer Analysis with the Agilent Bio-Monolith Protein A Column

mab Titer Analysis with the Agilent Bio-Monolith Protein A Column mab Titer Analysis with the Agilent Bio-Monolith Protein A Column Application Note Biopharmaceuticals and Biosimilars Authors Emmie Dumont, Isabel Vandenheede, Pat Sandra, and Koen Sandra Research Institute

More information

A Validated Stability Indicating HPTLC Method for Determination of Cephalexin in Bulk and Pharmaceutical Formulation

A Validated Stability Indicating HPTLC Method for Determination of Cephalexin in Bulk and Pharmaceutical Formulation International Journal of PharmTech Research CODEN( USA): IJPRIF ISSN : 0974-4304 Vol.1, No.3, pp 527-536, July-Sept 2009 A Validated Stability Indicating HPTLC Method for Determination of Cephalexin in

More information

Characterization of mab aggregation using a Cary 60 UV-Vis Spectrophotometer and the Agilent 1260 Infinity LC system

Characterization of mab aggregation using a Cary 60 UV-Vis Spectrophotometer and the Agilent 1260 Infinity LC system Characterization of mab aggregation using a Cary 60 UV-Vis Spectrophotometer and the Agilent 1260 Infinity LC system Application Note Biopharmaceuticals Authors Arunkumar Padmanaban and Sreelakshmy Menon

More information

Concentration of Human Hormones in Drinking Water Using Solid Phase Extraction and Analysis by High Performance Liquid Chromatography

Concentration of Human Hormones in Drinking Water Using Solid Phase Extraction and Analysis by High Performance Liquid Chromatography Concentration of Human Hormones in Drinking Water Using Solid Phase Extraction and Analysis by High Performance Liquid Chromatography Carl Fisher, Monika Verma, and Pranathi Perati; Thermo Fisher Scientific,

More information

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR DETERMINATION OF MICAFUNGIN AND ITS RELATED SUBSTANCES IN BULK BY RP-UPLC

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR DETERMINATION OF MICAFUNGIN AND ITS RELATED SUBSTANCES IN BULK BY RP-UPLC Joshi et al., IJPSR, 2016; Vol. 7(3): 1211-1218. E-ISS: 0975-8232; P-ISS: 2320-5148 IJPSR (2016), Vol. 7, Issue 3 (Research Article) Received on 16 September, 2015; received in revised form, 05 December,

More information

APPLICATION NOTE. UOP : Analysis of Trace CO and CO 2 in bulk H 2 and Light Gaseous Hydrocarbons by GC

APPLICATION NOTE. UOP : Analysis of Trace CO and CO 2 in bulk H 2 and Light Gaseous Hydrocarbons by GC UOP 63-13: Analysis of Trace CO and CO 2 in bulk H 2 and Light Gaseous Hydrocarbons by GC Fast Analysis in

More information

SensoLyte Anti-alpha-Synuclein Quantitative ELISA Kit (Human/Mouse/Rat) *Colorimetric*

SensoLyte Anti-alpha-Synuclein Quantitative ELISA Kit (Human/Mouse/Rat) *Colorimetric* Catalog # Kit Size SensoLyte Anti-alpha-Synuclein Quantitative ELISA Kit (Human/Mouse/Rat) *Colorimetric* AS-55550 One 96-well strip plate This kit is optimized to detect human/mouse/rat alpha-synuclein

More information

INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE

INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE REVIEW ON RP-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR BIO ANALYSIS OF VERAPAMIL IN RAT PLASMA VIVEK VIJAYAN SPPSPTM, NMIMS University,

More information

STANDARD OPERATING PROCEDURES

STANDARD OPERATING PROCEDURES PAGE: 1 of 5 CONTENTS 1.0 SCOPE AND APPLICATION 2.0 METHOD SUMMARY 3.0 SAMPLE PRESERVATION, CONTAINERS, HANDLING, AND STORAGE 4.0 INTERFERENCES AND POTENTIAL PROBLEMS 5.0 EQUIPMENT/APPARATUS 6.0 REAGENTS

More information

Investigation of Solid Phase Microextraction as an Alternative to Dried Blood Spot

Investigation of Solid Phase Microextraction as an Alternative to Dried Blood Spot Investigation of Solid Phase Microextraction as an Alternative to Dried Blood Spot Craig Aurand and Robert Shirey Supelco, Div. of Sigma-Aldrich Bellefonte, PA 16823 USA T414068 sigma-aldrich.com/analytical

More information

DRPK-005

DRPK-005 1114 Seaco Avenue Deer Park, TX 77536 Ph: (713) 844-3200 Fax: (713) 844-3330 Report of Analysis Submitted By: Address: Contact: Item No.: Client Ref. No.: Date Received: Testing Period: Country of Origin:

More information

Improved SPE for UPLC/MS Determination of Diquat and Paraquat in Environmental

Improved SPE for UPLC/MS Determination of Diquat and Paraquat in Environmental Improved SPE for UPLC/MS Determination of Diquat and Paraquat in Environmental Samples Michael S.Young, Jeremy C. Shia, Kim vantran, Kevin M. Jenkins and Masayo Yabo Waters Corporation 34 Maple Street,

More information

Method Development and Validation for Online UV-Dissolution Methods Using Fiber-Optic Technology

Method Development and Validation for Online UV-Dissolution Methods Using Fiber-Optic Technology Technical Overview Method Development and Validation for Online UV-Dissolution Methods Using Fiber-Optic Technology Introduction Online fiber-optic and multicell UV-dissolution systems have become increasingly

More information

Formulas: See Table 1 MW: Table 1 CAS: Table 1 RTECS: Table 1. METHOD: 2555, Issue 1 EVALUATION: PARTIAL Issue 1: 15 March 2003

Formulas: See Table 1 MW: Table 1 CAS: Table 1 RTECS: Table 1. METHOD: 2555, Issue 1 EVALUATION: PARTIAL Issue 1: 15 March 2003 KETONES I 2555 Formulas: See Table 1 MW: Table 1 CAS: Table 1 RTECS: Table 1 METHOD: 2555, Issue 1 EVALUATION: PARTIAL Issue 1: 15 March 2003 OSHA : See Table 2 NIOSH: See Table 2 ACGIH: See Table 2 PROPERTIES:

More information

Application Note. Author. Abstract. Biopharmaceuticals. Verified for Agilent 1260 Infinity II LC Bio-inert System. Sonja Schneider

Application Note. Author. Abstract. Biopharmaceuticals. Verified for Agilent 1260 Infinity II LC Bio-inert System. Sonja Schneider Combining small-scale purification and analysis of monoclonal antibodies on one instrument Protein purification with high-volume injection using the Agilent 126 Infinity Bio-inert Quaternary LC System

More information

Overview of preparative HPLC. Analytical Technologies Limited

Overview of preparative HPLC. Analytical Technologies Limited Overview of preparative HPLC Analytical Technologies Limited 1.Review of liquid phase chromatography origin develop prospect Mobile phase Tewett 1903 Stationa ry phase origin Separation result Liquid-stationary

More information

Generating Automated and Efficient LC/MS Peptide Mapping Results with the Biopharmaceutical Platform Solution with UNIFI

Generating Automated and Efficient LC/MS Peptide Mapping Results with the Biopharmaceutical Platform Solution with UNIFI with the Biopharmaceutical Platform Solution with UNIFI Vera B. Ivleva, Ying Qing Yu, Scott Berger, and Weibin Chen Waters Corporation, Milford, MA, USA A P P L I C AT ION B E N E F I T S The ability to

More information

Application Note. Kwasi Antwi, Amanda Ribar, Urban A. Kiernan, and Eric E. Niederkofler Thermo Fisher Scientific, Tempe, Arizona

Application Note. Kwasi Antwi, Amanda Ribar, Urban A. Kiernan, and Eric E. Niederkofler Thermo Fisher Scientific, Tempe, Arizona Analysis of an Antibody Drug Conjugate using MSIA D.A.R.T. S. Technology, an Integral Part of Ligand Binding Mass Spectrometric Immunoassay (LB-MSIA) Workflow Application Note Kwasi Antwi, Amanda Ribar,

More information

Verification of Compendial Methods

Verification of Compendial Methods Verification of Compendial Methods ภญ.ดร ดร.ส ภาณ ดวงธ รปร ชา ส าน กยาและว ตถ เสพต ด กรมว ทยาศาสตร การแพทย 7 ม ถ นายน 2556 1 Scopes : Overview Asean Analytical Validation Guidelines Verification of Compendial

More information

Gas Chromatography Assignment Chem 543/443

Gas Chromatography Assignment Chem 543/443 Gas Chromatography Assignment Chem 543/443 1. Introduction Capillary gas chromatography (GC) is one of the most popular analytical techniques used in today s research. Its popularity is mainly due to efficient

More information

AppNote 5/2006 ABSTRACT

AppNote 5/2006 ABSTRACT AppNote 5/26 Stir Bar Sorptive Extraction Based on Restricted Access Material for the Direct Extraction of Drugs and Metabolites in Biological Fluids Wayne M. Mullett and Elizabeth Kwong Merck Frosst,

More information

Exploring Extra Sensitivity Using ionkey/ms with the Xevo G2-XS Q-Tof HRMS for Small Molecule Pharmaceutical Analysis in Human Plasma

Exploring Extra Sensitivity Using ionkey/ms with the Xevo G2-XS Q-Tof HRMS for Small Molecule Pharmaceutical Analysis in Human Plasma Exploring Extra Sensitivity Using ionkey/ms with the Xevo G2-XS Q-Tof HRMS for Small Molecule Pharmaceutical Analysis in Human Plasma Yun Wang Alelyunas, Mark D. Wrona, Jim Murphy, Angela Doneanu, Gregory

More information

Forced Degradation of Ibuprofen in Bulk Drug and Tablets

Forced Degradation of Ibuprofen in Bulk Drug and Tablets Forced Degradation of Ibuprofen in Bulk Drug and Tablets and Deteration of Specificity, Selectivity, and the Stability-Indicating Nature of the USP Ibuprofen Assay Method Sherri Farmer, Pamela Anderson,

More information

Quantitation of cyanotoxins in drinking water according to EPA 544 guidelines

Quantitation of cyanotoxins in drinking water according to EPA 544 guidelines APPLICATION NOTE 64968 Quantitation of cyanotoxins in drinking water according to EPA 544 guidelines Authors Ali Haghani, 1 Andy Eaton, 1 Neloni Wijeratne, Claudia Martins 1 Eurofins Eaton Analytical,

More information

Chromatography Column Performance and Data Analysis Success Guide. Hints and Tips for Better Purifications

Chromatography Column Performance and Data Analysis Success Guide. Hints and Tips for Better Purifications Chromatography Column Performance and Data Analysis Success Guide Hints and Tips for Better Purifications This Chromatography Success Guide provides practical advice on preparative chromatography and protein

More information

Protocol for Quantitative Determination of Residual Solvents in Cannabis Concentrates Prepared by: Amanda Rigdon, May 23 rd, 2016

Protocol for Quantitative Determination of Residual Solvents in Cannabis Concentrates Prepared by: Amanda Rigdon, May 23 rd, 2016 Protocol for Quantitative Determination of Residual Solvents in Cannabis Concentrates Prepared by: Amanda Rigdon, May 23 rd, 2016 1.0 Method background: This method employs full evaporation technique headspace

More information

Thermo Scientific Peptide Mapping Workflows. Upgrade Your Maps. Fast, confident and more reliable peptide mapping.

Thermo Scientific Peptide Mapping Workflows. Upgrade Your Maps. Fast, confident and more reliable peptide mapping. Thermo Scientific Peptide Mapping Workflows Upgrade Your Maps Fast, confident and more reliable peptide mapping. Smarter Navigation... Peptide mapping is a core analytic in biotherapeutic development.

More information

HPLC to UPLC Method Migration: An Overview of Key Considerations and Available Tools

HPLC to UPLC Method Migration: An Overview of Key Considerations and Available Tools HPLC to UPLC Method Migration: An Overview of Key Considerations and Available Tools Dr. Michael Swartz, Ph. D. Principal Consulting Scientist Worldwide Pharmaceutical Business Operations Waters Corporation

More information

Simultaneous in vivo Quantification and Metabolite Identification of Plasma Samples Using High Resolution QTof and Routine MS E Data Analysis

Simultaneous in vivo Quantification and Metabolite Identification of Plasma Samples Using High Resolution QTof and Routine MS E Data Analysis Simultaneous in vivo Quantification and Metabolite Identification of Plasma Samples Using High Resolution QTof and Routine MS E Data Analysis Mark Wrona, 1 Paul Rainville, 1 Eric Langlois, 2 Nigel Ewing,

More information

Bio-Monolith Protein G Column - More Options for mab Titer Determination

Bio-Monolith Protein G Column - More Options for mab Titer Determination Bio-Monolith Protein G Column - More Options for mab Titer Determination Application Note Biologics and Biosimilars Author Phu T. Duong Agilent Technologies, Inc. Introduction In recent years, monoclonal

More information

PART II: SAMPLING AND SALIVA SAMPLE PRETREATMENT

PART II: SAMPLING AND SALIVA SAMPLE PRETREATMENT PART II: SAMPLING AND SALIVA SAMPLE PRETREATMENT IBIB PAN PROJECT TEAM A. MOOS 1, K. DUDZIŃSKI 2, P. KNIHNICKI 1, P. KOŚCIELNIAK 1,3, J. NOWAK 1, D.G. PIJANOWSKA 2, B. ROZUM 2, M. WIECZOREK 1, R. WIETECHA-POSŁUSZNY

More information

Dynamic High Capacity Mustang Q Membrane Units for Scaleable Anion Exchange Chromatography Purification of Adenoviral Vectors

Dynamic High Capacity Mustang Q Membrane Units for Scaleable Anion Exchange Chromatography Purification of Adenoviral Vectors Contact Us: www.pall.com/contact Dynamic High Capacity Mustang Q Membrane Units for Scaleable Anion Exchange Chromatography Purification of Adenoviral Vectors Dynamic High Capacity Mustang Q Membrane Units

More information

Saudi Journal of Medical and Pharmaceutical Sciences. Research Article. Available Online: 70

Saudi Journal of Medical and Pharmaceutical Sciences. Research Article. Available Online:  70 Saudi Journal of Medical and Pharmaceutical Sciences Scholars Middle East Publishers Dubai, United Arab Emirates Website: http://scholarsmepub.com/ ISSN 2413-4929 (Print) ISSN 2413-4910 (Online) Research

More information

Validation Report 16

Validation Report 16 EURL for Cereals and Feeding stuff National Food Institute Technical University of Denmark Validation Report 16 Determination of pesticide residues in wheat, barley and rice by GC-MS/MS and LC-MS/MS (QuEChERS

More information

Analysis of 16 Pesticide Residues in Broccoli Using CarbonX dspe QuEChERS AOAC Kits Using GC/MS

Analysis of 16 Pesticide Residues in Broccoli Using CarbonX dspe QuEChERS AOAC Kits Using GC/MS Analysis of 16 Pesticide Residues in Broccoli Using CarbonX dspe QuEChERS AOAC Kits Using GC/MS Authors: Conor Smith, Doug Fryer United Science Corp. 15911 Furuby Rd. Center City, MN 55012 USA Abstract

More information

[ product solution ] Waters Oasis µ Elution PlateS. Patented Innovation. Elution volume as low as 25 μl. No evaporation and reconstitution

[ product solution ] Waters Oasis µ Elution PlateS. Patented Innovation. Elution volume as low as 25 μl. No evaporation and reconstitution [ product solution ] Waters µ Elution PlateS Elution volume as low as 25 μl No evaporation and reconstitution Ideal for small sample volumes Up to a 15x increase in concentration Patented Innovation Now

More information

Separation and Quantitation of a Mixture of Alcohols by Gas Chromatography

Separation and Quantitation of a Mixture of Alcohols by Gas Chromatography Separation and Quantitation of a Mixture of Alcohols by Gas Chromatography 1. Purpose This procedure will determine the percentage of two alcohols in an unknown aqueous mixture. 2. Background Gas chromatography

More information

ICH Guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - questions and answers

ICH Guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - questions and answers 14 December EMA/CHMP/ICH/320985/2016 Committee for Medicinal Products for Human Use ICH Guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - questions

More information

Analysis of the bioactive components from different growth stages of Fritillaria taipaiensis P. Y. Li

Analysis of the bioactive components from different growth stages of Fritillaria taipaiensis P. Y. Li Acta Pharmaceutica Sinica B 2013;3(3):167 173 Institute of Materia Medica, Chinese Academy of Medical Sciences Chinese Pharmaceutical Association Acta Pharmaceutica Sinica B www.elsevier.com/locate/apsb

More information

Maximizing Chromatographic Resolution of Peptide Maps using UPLC with Tandem Columns

Maximizing Chromatographic Resolution of Peptide Maps using UPLC with Tandem Columns Maximizing Chromatographic Resolution of Peptide Maps using UPLC with Tandem Columns Hongwei Xie, Martin Gilar, and Jeff Mazzeo Waters Corporation, Milford, MA U.S. APPLICATION BENEFITS The ACQUITY UPLC

More information

A Fast and Robust Linear ph Gradient Separation Platform for Monoclonal Antibody (MAb) Charge Variant Analysis

A Fast and Robust Linear ph Gradient Separation Platform for Monoclonal Antibody (MAb) Charge Variant Analysis A Fast and Robust Linear ph Gradient Separation Platform for Monoclonal Antibody (MAb) Charge Variant Analysis Shanhua Lin, Julia Baek, and Chris Pohl Thermo Fisher Scientific, Sunnyvale, CA, USA Overview

More information

R R Innovation Way P/N SECKIT-7830 Newark, DE 19711, USA Tel: Fax: Website: Published in November 2013

R R Innovation Way P/N SECKIT-7830 Newark, DE 19711, USA Tel: Fax: Website:  Published in November 2013 5-100 Innovation Way Newark, DE 19711, USA Tel:302-3661101 Fax:302-3661151 Website: www.sepax-tech.com Published in November 2013 P/N SECKIT-7830 These Phases are developed based on innovative surface

More information

LabChip GXII: Antibody Analysis

LabChip GXII: Antibody Analysis WHITE PAPER LabChip GXII: Antibody Analysis Antibody Analysis using microfluidic technology in high throughput Quality by Design Experiments Abstract Current initiatives in Process Analytical Technology

More information

Qualification of High-Performance Liquid Chromatography Systems

Qualification of High-Performance Liquid Chromatography Systems Qualification of High-Performance Liquid Chromatography Systems L. Huber Hewlett- Packard GmbH, Waldbronn December 1998 Manuscript of an article published in BioPharm, Vol 11 Number 11, November 1998,

More information

Protein-Pak Hi Res HIC Column and HIC Protein Standard

Protein-Pak Hi Res HIC Column and HIC Protein Standard Protein-Pak Hi Res HIC Column and HIC Protein Standard CONTENTS I. INTRODUCTION II. a. Mobile Phase b. Flow Direction CONNECTING COLUMN TO LC SYSTEM I. INTRODUCTION This offering contains non-porous, polymethacrylate-based

More information

Method Translation in Liquid Chromatography

Method Translation in Liquid Chromatography Method Translation in Liquid Chromatography Technical Overview Abstract Ronald E. Majors Agilent Technologies, Inc. 2850 Centerville Rd Wilmington, DE 19808 USA With the recent emphasis on high performance

More information

QUESTIONS AND ANSWERS TO ICH S3A: NOTE FOR GUIDANCE ON TOXICOKINETICS: THE ASSESSMENT OF SYSTEMIC EXPOSURE IN TOXICITY STUDIES FOCUS ON MICROSAMPLING

QUESTIONS AND ANSWERS TO ICH S3A: NOTE FOR GUIDANCE ON TOXICOKINETICS: THE ASSESSMENT OF SYSTEMIC EXPOSURE IN TOXICITY STUDIES FOCUS ON MICROSAMPLING INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE QUESTIONS AND ANSWERS TO ICH S3A: NOTE FOR GUIDANCE ON TOXICOKINETICS: THE ASSESSMENT

More information

UHPLC Separation of Triazine Herbicides at Elevated Temperature

UHPLC Separation of Triazine Herbicides at Elevated Temperature Application ote: 453 UPLC Separation of Triazine erbicides at Elevated Temperature Dave Thomas, Thermo Fisher Scientific, San Jose, CA USA Key Words Accela UPLC Environmental Analysis erbicides igh Temperature

More information

A2LA. R231 Specific Requirements: Threat Agent Testing Laboratory Accreditation Program. December 6, 2017

A2LA. R231 Specific Requirements: Threat Agent Testing Laboratory Accreditation Program. December 6, 2017 Laboratory Page 1 of 17 Laboratory December 6, 2017 2017 by A2LA All rights reserved. No part of this document may be reproduced in any form or by any means without the prior written permission of A2LA.

More information

Validation of Thin Layer Chromatographic Procedures

Validation of Thin Layer Chromatographic Procedures Validation of Thin Layer Chromatographic Procedures International Symposium for High-Performance Thin-Layer Chromatography HPTLC 2011 July 7th, 2011, Basle Topics ICH Q2(R1) and nothing else? Other guidance

More information

Fast Preparative Column Liquid Chromatography (PCLC)

Fast Preparative Column Liquid Chromatography (PCLC) Fast Preparative Column Liquid Chromatography (PCLC) Application Note 224 Joan Stevens, Ph.D. and Gary Scharrer Introduction Preparative HPLC is recognized as a prime method for obtaining pure compounds

More information